Putting Patients First: Pragmatic Trials in Gynecologic Oncology

Area of Science:

• Oncology
• Clinical Trials
• Health Services Research

Background:

• The Society of Gynecologic Oncology of Canada convened an interdisciplinary workshop in November 2024.
• The workshop aimed to establish an initiative for developing and promoting pragmatic clinical trials (PCTs) in Canadian gynecologic oncology research.

Purpose of the Study:

• To emphasize foundational elements of pragmatism in PCTs.
• To demonstrate the real-world effectiveness of interventions across diverse patient populations.
• To present how PCT outcomes can influence clinical decision-making and health policy based on patient-prioritized outcomes.

Main Methods:

• Brought together diverse stakeholders: ovarian cancer patients, patient advocates, PCT experts, gynecologic oncologists, medical oncologists, and clinical fellows.
• Focused on the core principles of pragmatism and the goal of PCTs.
• Incorporated patient and advocate input in co-designing PCT protocols.

Main Results:

• Several new PCT proposals were developed, guided by patient input.
• Emphasis was placed on patient-centered outcomes such as overall survival and quality of life.
• The workshop highlighted the essential role of patients and advocates in research design.

Conclusions:

• The workshop successfully initiated a collaborative effort to advance PCTs in gynecologic oncology.
• Patient engagement is vital for ensuring PCTs address relevant questions and outcomes.
• Future educational initiatives are planned to further involve clinical investigators in PCT development.